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目的:建立心宝丸中冰片含量的气相色谱测定方法,并研究生产过程中冰片含量的变化。方法:采用气相色谱内标法,CBP20-M25-0.25(SHIMADZU)毛细管柱,火焰离子化检测器(FID),以N2为载气;进样口温度220℃,检测器温度240℃,应用程序升温:初始温度90℃,以10℃/min升至160℃,保持5 min;结果:冰片在0.1587~4.2336 mg/mL的范围内呈良好线性关系(r=0.9994),回收率为99.4%(n=9),RSD=1.55%。结论:本法简便、准确,可用于制剂和生产过程中间产品的质量控制。
OBJECTIVE: To establish a gas chromatographic method for determination of content of Xinbao Pills in borneol, and to study the changes in borneol content during production. Method: Gas chromatography internal standard method, CBP20-M25-0.25 (SHIMADZU) capillary column, flame ionization detector (FID), N2 as carrier gas; inlet temperature 220°C, detector temperature 240°C, application program Temperature rise: The initial temperature was 90°C, and the temperature was raised from 10°C/min to 160°C for 5 min. Results: The borneol showed a good linear relationship (r=0.9994) in the range of 0.1587-4.2336 mg/mL. The recovery rate was 99.4% ( n=9), RSD=1.55%. Conclusion: This method is simple and accurate and can be used for the quality control of intermediate products in the preparation and production process.